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September 2010 Updates

Experts Admit GM Brinjal Report Fault

By G.S. Mudur
Telegraph India
September 26, 2010

New Delhi: The heads of India's science academies today conceded that they had unknowingly used a plagiarised report to declare that genetically-modified (GM) brinjal is safe and said that they would correct the mistake.

Six Indian science academies had earlier this week approved the limited release of GM brinjal for cultivation in a joint report that contained 60 lines of plagiarised text, a near verbatim reproduction of an article in a biotechnology advocacy newsletter which itself had lines extracted from an industry-supported publication.

"This is unfortunate - we are devastated. This should not have happened," said M. Vijayan, the president of the Indian National Science Academy, and a senior faculty member at the Indian Institute of Science (IISc), Bangalore.

The academies will now examine the report again, introduce references for all text extracted from earlier publications, and release the names of all the scientists who contributed to the report, Vijayan told The Telegraph. But, he said, the main recommendations are unlikely to change.

The report had recommended limited release of GM brinjal for cultivation to be followed by surveillance to look for effects, if any, on the health of people.

In preparing the report, the academies had relied on oral, written, and documentary information provided by fellows of the academy, and the error appeared to have occurred in this process, another head of an academy said.

"There is absolutely no justification for what has happened," said Ajay Sood, president of the Indian Academy of Sciences, Bangalore and a professor of physics at the IISc, Bangalore. "But many scientists are involved in the consultations - we cannot police each other."

A coalition of environmental groups has said the cut-and-paste job in the report suggests that instead of pursuing an independent and rigorous evaluation of GM crop science, the academies appeared to have relied on scientists known to be leaning towards GM crops.

"Where is the independent, non-biased scientific review?" the coalition said in a statement today.

The coalition had yesterday shown that a section of the academies' report contained text from an article written by P. Ananda Kumar, director of the National Centre for Plant Biotechnology, New Delhi, who has himself been involved in developing GM brinjal since the mid-1990s.


FDA Hears Concerns over Approving Genetically Modified Salmon

By Lyndsey Layton
Washington Post
September 20, 2010

Environmental organizations, consumer groups and independent researchers assailed the plans of a Massachusetts company to market the first genetically modified animal as food in the United States - an Atlantic salmon - and argued at a public meeting Monday that federal regulators should deny permission.

"Science cannot prove that this new gene-spliced salmon is safe for human consumption over a long period of time," said Darrell Rogers of the Alliance for Natural Health. "This recklessly and needlessly endangers human health."

He made the comments at a meeting of a panel of experts convened by the Food and Drug Administration, which is poised to make a landmark decision that could mark a turning point in the way American food is produced.

AquaBounty, the company seeking permission to market the fish in the United States, wants to incubate genetically modified eggs in Prince Edward Island, Canada, then ship them in plastic coolers to Panama. There they would be raised in land-based tanks and eventually processed before being transported to the United States for sale.

In developing its fish, AquaBounty took an Atlantic salmon and inserted a growth hormone gene from a Chinook salmon as well as an "antifreeze" gene from the ocean pout, a large, eel-like species. The result is a genetically modified fish that can grow to market size in 18 months instead of three years, according to AquaBounty. That means farmers can speed production and increase yields, the company said.

The advisory panel did not vote on the matter, but individual members offered a range of comments - sometimes conflicting - after two days of testimony from AquaBounty, the FDA and the public.

Gregory Jaffe, a panel member who is the biotechnology director at the Center for Science in the Public Interest, said the committee did not find any fatal flaws in the application.

"In some areas, we said we need more information to do the analysis," Jaffe said. "I think the agency is going to take its time with this, but I anticipate at some point this will be approved by the FDA."

A separate panel will meet Tuesday to discuss whether the FDA should require labeling on the modified salmon. The FDA commissioner will decide both matters, but it is unclear when.

AquaBounty, which first applied to the FDA for permission to sell its fish in 1995, says the modified fish is identical to the Atlantic salmon except for the speed of its growth.

FDA scientists who reviewed the company's application agreed. "AquAdvantage salmon is Atlantic salmon," said Kathleen Jones, an FDA scientist. "AquAdvantage salmon is as safe as food from any other Atlantic salmon."

Agency scientists also agreed with AquaBounty's assertion that the modified fish would not pose a threat to the environment.

"The likelihood that these fish could escape and reproduce and establish themselves is extremely small," said Eric Silberhorn of the FDA, noting that the fish would be raised in physically contained tanks and would be sterile females, unable to mate.

Critics said the company had not proved that the fish was safe for humans or the environment.

"If you tried to publish this information in a peer-reviewed journal, it would be rejected," said Anne Kapuscinski, a professor at Dartmouth College and an international expert on the safety of genetically modified organisms.

She said that AquaBounty's application was built on "overly simplistic claims" and that the FDA had not thoroughly analyzed the impact of a modified salmon if it escaped into the ocean.

"There are always human errors or equipment failures, and you have to analyze what would happen under those circumstances," Kapuscinski said.

Ron Stotish, the chief executive of AquaBounty, said his company had spent $60 million and 10 years developing and studying the AquAdvantage salmon. "The data we supplied adequately supports our application," he said. "Any fair-minded person would find this to be fairly complete."

Several public speakers argued that the FDA's approval process is not designed to handle the complexities of genetically engineered organisms. The agency is treating the application for AquAdvantage salmon as if it were a new veterinary drug, which means that the deliberations are taking place behind closed doors and that AquaBounty can say much of the research and other supporting data it supplies to the agency is confidential.

The pending decision is being carefully tracked by biotechnology companies that have invested millions of dollars in developing other genetically modified food animals and are next in line behind AquaBounty, waiting for the FDA to act on their requests for approval. The U.S. already permits genetically modified plants, such as corn and soybean.


FDA Committee (VMAC) Split on Recommendations about Controversial Genetically Engineered Salmon

Press Release
Center for Food Safety
September 20, 2010

The Center for Food Safety today commended the U.S. Food and Drug Administration's (FDA) Veterinary Medicine Advisory Committee (VMAC) for taking a critical look at whether FDA should approve the long-shelved AquaBounty transgenic salmon as the first genetically engineered (GE) animal intended for human consumption.

"While several presentations and comments during the meetings today show just how beholden the FDA, including members of the Advisory Committee, is to the biotechnology industry," said Andrew Kimbrell, Executive Director for the Center for Food Safety, "Other members of the VMAC criticized the poor science done by AquaBounty and demanded FDA require full and more comprehensive food safety and environmental reviews including a full environmental impact statement (EIS)." One Committee member noted that there lacks adequate evidence to determine if this fish is truly safe.

In comments delivered to the VMAC today, Jaydee Hanson, Senior Policy Analyst at the Center for Food Safety, noted that "FDA should have developed a more fulsome novel foods approach that included adequate feeding trials assessing this animal as a human and animal food." FDA itself even details problems with the AquaBounty data and at times described it to be of limited value. "The environmental assessment presented by AquaBounty is a wholly inadequate review for this fish," added Hanson.

The meetings, which began yesterday and ended today, are part of an approval process announced by FDA on August 25, 2010, which gave the public a narrow window of opportunity to review the limited data made available and provide public comment regarding the environmental and food safety concerns associated with the transgenic salmon. FDA plans to approve the GE salmon as a "veterinary drug," a review process conceived before GE products became a reality. If the GE fish is approved, Agency officials are undecided as to whether they will require product labeling.

"The public comments given today underscored the numerous environmental, food safety, and economic risks and concerns this GE fish may pose," said Jaydee Hanson, Senior Policy Analyst for the Center for Food Safety. Dr. Gary Thorgaard, the only member of the Committee with expertise on fisheries, called on FDA to conduct an Environmental Impact Statement, a sentiment echoed by other members of the Committee during the discussion period. "The Committee raised many of its own concerns regarding small sample sizes, incomplete data, culling practices, and poor scientific assessments over the past two days, and pointed to the complexity and numerous uncertainties that remain," added Hanson.

Over 300 environmental, consumer, health, and animal welfare organizations, along with salmon and fishing groups and associations, food companies, chefs and restaurants signed joint letters to the FDA opposing the approval of AquaBounty's GE salmon. CFS and a coalition of allied groups also submitted over 160,000 comments from individuals opposing the approval. In addition, 14 members of the California State Legislature sent a letter to FDA and President Obama requesting that FDA deny the approval until the full suite of environmental and food safety concerns are addressed.

The genetically engineered Atlantic salmon being considered was developed by AquaBounty Technologies, which artificially combined growth hormone genes from an unrelated Pacific salmon, (Oncorhynchus tshawytscha) with DNA from the anti-freeze genes of an eelpout (Zoarces americanus). This modification causes production of growth-hormone year-round, creating a fish the company claims grows at twice the normal rate, allowing factory fish farms to crowd fish into pens and still get high production rates.

Genetically engineered fish pose serious risk to wild populations of fish. Each year millions of farmed salmon escape into the wild, outcompeting native populations for resources and straining ecosystems. "We believe any approval of the salmon would represent a serious threat to the survival of native salmon populations already teetering on the brink of extinction," said Kimbrell. In a presentation before the VMAC today, AquaBounty CEO Ronald Stotish reasserted the company's desire to raise fish closer to populations and consumption centers, a comment that had to be redacted by FDA staff. "Stotish's comments to VMAC today further exemplify the backdoor approval process that we feared from FDA."

AquaBounty filed a New Animal Drug (NAD) application for AquAdvantage salmon with FDA in 2001, yet the agency chose not to disclose any data relating to its decision until just 10 working days before the public meeting. Hanson noted, "The data FDA provided to the public on food safety is altogether deficient given that the FDA has had 10 years to review the product."

If FDA approves the GE salmon, the fish would be bred in the broodstock facility in Canada and fertilized, triploid eggs would be shipped to the grow-out facility in Panama, where they would be raised to market size. Yet the stipulation that the FDA tries to place on the approval, namely that the eggs be raised in Canada and the fish raised in Panama, ignores the easy transfer of a material like eggs in the international market. A full environmental impact statement should be required before the approval of the fish.

FDA announced yesterday that after the VMAC meetings, the Agency plans to publish the final environmental assessment (EA) as well as issue a notice in the Federal Register establishing a 30-day public comment period on the EA. A second FDA public meeting is scheduled for tomorrow, September 21, 2010 to discuss the labeling of food from the transgenic salmon. A 60-day public comment period on the labeling issue will be open until November 22, 2010.

In light of the numerous unknowns raised throughout the two day meeting, FDA officials announced that any approval will require post-market review and data requirements. Yet the VMAC expressed its concerns with FDA's plan to require post-market reviews as sufficient for gaps in current safety data. "If there are concerns about safety then they should be addressed before going on the market, not after," one Committee member stated.

"Today the public provided a resounding objection to GE fish and we hope that FDA will take heed," said Kimbrell. "We strongly oppose the approval of these genetically engineered salmon and urge FDA to reject this application."

Survey on FDA approval of GE salmon


FDA Hearing Focuses on the Labeling of Genetically Engineered Salmon

By Andrew Pollack
New York Times
September 21, 2010

ROCKVILLE, Md. - So what do you call a salmon that is genetically engineered to grow fast?

If it is allowed to be sold in supermarkets, some consumer and environmental groups want it to be labeled as just that - so the engineered salmon cannot be mistaken for the regular fish. But the Food and Drug Administration says such a label might not be possible under its regulations.

The labeling issue was the focus of a daylong hearing here Tuesday as the F.D.A. considers whether to approve the sale of the genetically engineered salmon, which grow to market size in about half the time as regular salmon.

If approved, the salmon would be the first genetically engineered animal to enter the American food supply. The F.D.A. made no ruling on the labeling, but officials made clear that the agency was not permitted to change the label on a food merely because it was genetically engineered. The food itself must be different - in its taste, nutrition or safety, for example. For the same reason, no labels about genetic engineering appear on the many foods now sold that contain genetically modified corn and soybeans.

The consumer groups, which do not want the salmon approved at all, disputed the F.D.A.'s interpretation of the regulations. The groups also said that in an era in which people pay more attention to the sources of their food, they had a right to know when a product was genetically engineered.

"The least you can do if you put these products on the market is to let consumers decide for themselves, and you need labeling to do that," said Patricia Lovera of Food and Water Watch, an advocacy group. "Every trend in the food industry shows consumers want more information, not less."

But AquaBounty Technologies, the Boston-area company that developed the salmon, suggested that a "genetically engineered" label would be akin to a skull and crossbones, killing sales. Elliot Entis, a founder of AquaBounty, said critics were trying to "delegitimize the product through labeling."

Some representatives of the food and biotechnology industries supported the F.D.A.'s policy about labeling. "The food label is not a playground for every bit of information someone wants to know," said David B. Schmidt, president of the International Food Information Council, an industry group.

If there were no requirement to label the fish, AquaBounty or companies that market its fish could voluntarily label it. It is more likely, however, that other fish companies would want to label their products as not being genetically engineered.

But the F.D.A. has said even that labeling could run into roadblocks. Labeling must not be false and misleading, such as by implying that the nonengineered fish was in some way superior to the engineered fish. The agency has stopped some milk producers from labeling their product as coming from cows not injected with bovine growth hormone unless they include a statement that the F.D.A. had found that there is no difference between milk from treated and untreated cows.

The timetable for approval of the salmon is not clear.

In a meeting Monday, F.D.A. advisers faulted some studies the agency used to conclude that the salmon was safe for people and the environment, though they did not say the fish was dangerous. If the F.D.A. were to now order AquaBounty Technologies to do more studies, any approval could be delayed by months.


Misguided FDA Opposition to Labeling Could Leave Public Permanently in the Dark ON GE Animals

Press Release
Center for Food Safety
September 21, 2010

Rockville, MD - After a two-day public hearing on the approval of the first genetically engineered (GE) animal intended for human consumption, the AquAdvantage GE salmon, FDA held a public hearing today to discuss whether or not these GE fish should be labeled as such should they be approved. A 60-day public comment period on the labeling issue will be open until November 22, 2010.

"This transgenic salmon is the first GE animal intended for food, yet the human health impacts of eating these GE fish are completely unknown," said Andrew Kimbrell, Executive Director at the Center for Safety (CFS). "These GE fish also pose unacceptable risks to wild salmon and the marine environment." These "unknowns" were raised repeatedly at yesterday's Veterinary Medicine Advisory Committee (VMAC) hearing, and the Committee was unable to come to any conclusion as to the safety or efficacy of the GE salmon. The hearing on labeling is premature given that the VMAC has not approved this salmon for human or animal consumption.

The public has not been quiet about the possible approval of GE salmon. In fact, over 300 environmental, consumer, health, and animal welfare organizations, along with salmon and fishing groups and associations, food companies, chefs and restaurants signed joint letters to the FDA opposing the approval of AquaBounty's GE salmon. CFS and a coalition of allied groups also submitted 172,000 comments from individuals opposing the approval and urging clear, mandatory labeling should the fish be approved despite overwhelming public opposition (CFS comments to the VMAC and the joint letters can be found on our website).

Announcements by FDA officials and speakers today suggest that the Agency may not require labeling of GE salmon should it be approved. While FDA is operating under the fiction that transgenic animals are "new drugs," the Agency does not feel that they need to be labeled in the same way that drugs are.

A Lake Research Partners poll commissioned by Food & Water Watch and released yesterday found that 91 percent of Americans believe FDA should not allow genetically engineered fish and meat into the marketplace; 83 percent felt strongly that it should not be allowed. Additionally, a 2008 Consumers Union nationwide poll found that 95 percent of respondents said they thought food from genetically engineered animals should be labeled, and 78 percent strongly agreed with this.

In his comments today, CFS Senior Staff Attorney George Kimbrell asserted that "labeling in the 21st Century cannot be based on 20th Century policy decisions." The FDA currently uses its 1992 interpretation of "material" to inform its decisions on labeling, an interpretation that occurred prior to commercialization of any transgenic animal.

CFS and others have also criticized the process established by FDA. "After the numerous concerns raised by the VMAC yesterday, it is inappropriate to hold a hearing on the labeling of a product the Agency has yet to approve," said George Kimbrell. To ensure meaningful public comment and confidence in the Agency's processes, the agency should have separately convened the labeling hearing, after any initial decision on approval. "This is a backwards process at best and a dog and pony show at worst - labeling is not an adequate substitution for proper regulation and safety assessments," added Kimbrell.

Apparently heeding public outcry about the lack of a public comment period on the approval of GE salmon itself, FDA announced yesterday that after the VMAC meetings, the Agency plans to publish the final environmental assessment (EA) as well as issue a notice in the Federal Register establishing a 30-day public comment period on the EA.

"It is totally unacceptable for GE fish not to be labeled if approved for commercial use," said Jaydee Hanson, Senior Policy Analyst at the Center. "Consumers want more information about the foods they buy and feed to their families, not less. Leaving consumers in the dark not only prohibits them from making informed choices, but without mandatory tracking and labeling of these GE fish we may be putting public health at risk as well."

"We strongly oppose FDA approval of GE salmon," said Andrew Kimbrell. "Should FDA decide to approve the AquAdvantage GE salmon despite overwhelming consumer opposition and potential threats to the environment, human health, and native salmon populations, we urge that clear, mandatory labeling be unconditional."


Parnell Joins Opposition to Genetically Engineered Salmon

By Margaret Bauman
The Cordova Times
September 25, 2010

Gov. Sean Parnell has joined growing opposition in Alaska to putting genetically engineered Atlantic salmon on the market for human consumption.

Parnell said in a statement issued today that genetically engineered salmon pose significant potential threats to the environment, consumer health and the wild seafood industry.

His opponent in the gubernatorial race, Democrat Ethan Berkowitz, along with Senators Mark Begich, D-Alaska, and Lisa Murkowski, R-Alaska, spoke out earlier against making genetically modified fish available for human consumption.

Parnell also released a copy of correspondence sent Sept. 23 to Margaret Hamburg, commissioner of the U.S. Food and Drug Administration. The letter was written three days after several members of an advisory panel to the FDA found that there are not sufficient amounts of data to determine whether a genetic modification that enables salmon to speed their growth is safe for either the fish or for consumers.

In his letter, Parnelll questioned whether the application from AquaBounty Technologies has received sufficient scientific and public scrutiny, adding that the state is "troubled by the lack of transparency that has marked the review process."

"There is no room for 'Frankenfish' in our waters, our nets or our kitchens," Berkowitz said. "It's a position I share with our congressional delegation. Apparently, the FDA now also agrees that it would be premature to certify the safety of genetically engineered fish."

Among the concerns Parnell expressed in his letter to Hamburg were the possibility of salmon escaping from areas where they are reared and mingling with wild stocks. "That risk would grow if AquaBounty supplies genetically engineered salmon eggs to a network of commercial farms, as the company intends," Parnell said.

The genetically altered salmon eggs that AquaBounty Technologies proposes to use include a growth hormone gene that causes them to grow to full size in about half the time of non-genetically engineered salmon.

A complete copy of Parnell's letter is at

Begich issued a statement on Sept. 8, calling the potential approval of genetically modified salmon for human consumption "unprecedented, risky and a threat to the survival of wild species. Let's call this genetically engineered fish for what it is -Frankenfish," he said.

Murkowski also urged the FDA not to approve genetically modified Atlantic salmon for human consumption. "We have seen too many problems with impacts of farmed salmon already to risk something like this," she said in a statement Sept. 10. "

"Putting unlabeled, genetically altered salmon in the marketplace is simply irresponsible and the FDA needs to strongly consider what impacts this will have before they approve this Frankenfish," she said.

Read Gov. Parnell's letter

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